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Liposome-Encapsulated Doxorubicin (LED) in Hormone Refractory Prostate Carcinoma, Phase II (NCT00004014)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with prostate cancer that has not responded to hormone therapy.
  • Drug: pegylated liposomal doxorubicin hydrochloride
    Doxorubicin HCl liposome IV over 45 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 9 weeks thereafter.
    Ages eligible for Study
    all
    Genders eligible for Study
    Male
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Estimate the objective response rate of patients with hormone refractory prostate cancer treated with doxorubicin HCl liposome. II. Determine the toxic effects (including any cumulative cardiotoxicity) of this regimen in these patients. III. Assess the effect of this regimen on pain and quality of life of these patients.

    OUTLINE: Patients receive doxorubicin HCl liposome IV over 45 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 9 weeks thereafter. Patients are followed every 3 months.

    PROJECTED ACCRUAL: Approximately 50 evaluable patients will be accrued for this study.

    1 locations

    United States (1)
    • Ireland Cancer Center at University Hospitals Case Medical Center
      Cleveland, Ohio, United States, 44106-5065
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 March, 1999
    Updated:
    12 August, 2010
    Participants:
    10
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